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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025256
Receipt No. R000026916
Scientific Title Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Date of disclosure of the study information 2016/12/13
Last modified on 2016/12/13

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Basic information
Public title Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Acronym Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Scientific Title Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Scientific Title:Acronym Benefits of supplemental oxygen on exercise capacity and dyspnea in IPF patients
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis
Classification by specialty
Pneumology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to assess the effect of supplemental oxygen on exercise capacity in IPF patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes endurance time of constant work-rate test
Key secondary outcomes dyspnea, leg fatigue (Borg scale)
(before and every 1 minute and end of oxygen therapy)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 oxygen gas
Interventions/Control_2 air gas
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria (i) diagnosis of IPF
(ii) shortness of breath on effort
(iii) stable clinical condition with no infection or exacerbation in the previous three months.
Key exclusion criteria severe comorbid illnesses, collagen vascular diseases, and the need for long-term oxygen therapy.
Target sample size 106

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Taniguchi
Organization Tosei General Hospital
Division name Department of Respiratory Medicine and Allergy
Zip code
Address 160 Nishioiwake-cho, Seto, Aichi 489-8642, Japan
TEL 0561-82-5101
Email taniguchi@tosei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Arizono
Organization Seirei Christopher University,
Division name School of Health Sciences
Zip code
Address 3453 Mikataha Kitaku, Hamamatsu, Shizuoka
TEL 053-439-1400
Homepage URL
Email arizono-s@umin.ac.jp

Sponsor
Institute Tosei General Hospital
Institute
Department

Funding Source
Organization Grant-in-Aid for scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 公立陶生病院

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 13 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Supplemental oxygen increased endurance time than supplemental placebo air(oxygen: 546.5 sec vs placebo air: 427.8 sec, p<0.05). Dyspnea and leg fatigue at isotime were improved significantly by supplemental oxygen.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2016 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026916

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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